BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 260051 · Received January 20, 2000

    Report

    Report Number
    1451914-2000-00001
    Event Type
    Other
    Date Received
    January 20, 2000
    Report Date
    January 19, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 12/21/1999, THE ACCOUNT OBTAINED A NEGATIVE HCG TESTPACK RESULT WITH A FIRST MORNING URINE SAMPLE. A HUMAN CHORIONIC GONADOTROPIN QUANTITATIVE TEST, METHOD UNKNOWN, WAS PERFORMED ON A SERUM SAMPLE AND A RESULT OF 122 MIU/ML WAS OBTAINED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 48901M300

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death LOT NUMBER 48901M300, EXPIRATION DATE 04/28/2000.